Clinical trials: Infant Development
- Condition Infant Development
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Child Development
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control…
- Trial name
- NCT04013087
- Testing
- Oral feeding of Feihe Stage 1 infant formula, Oral feeding of control Stage 1 formula, Breast feeding
- Where
- 3 sites in China
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Infant Developmental Assessment
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or…
- Trial name
- NCT01362660
- Testing
- Unintentional exposure in utero
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Pfizer
Infant Development
Effect of a New Infant Cereal on Weight Gain
The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .
- Trial name
- CEOBE (NCT02165956)
- Testing
- New Infant Cereal, Standard Infant Cereal
- Where
- 5 sites in Spain
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Laboratorios Ordesa
Dermatitis, Atopic, Eczema, Infantile
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
- Conditions
- Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development
- Trial name
- GIraFFE (NCT04599946)
- Testing
- Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
- Where
- 12 sites in Germany, Poland and 1 more
- Volunteers
- 2,132 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Infant Development, Glucose, High Blood
Effect of Nutritional Intervention on Metabolic Response in Infants
The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).
- Trial name
- NCT04483453
- Testing
- EXPL feeding regimen, CTRL feeding regimen
- Where
- Philippines
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Allergy
The Prolonged Effect of Consumption of a Partially Hydrolyzed Infant Formula During the First 6 Months of Life on the Development of Allergic Manifestations At 5 Years of Age
The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T.
- Trial name
- NCT05418491
- Testing
- No intervention is used in the current study. Interventions were given in the original A.R.T. study
- Where
- 3 sites in Bulgaria, Cyprus and 1 more
- Volunteers
- 455 people
- Sponsor
- FrieslandCampina
Infant Development
Effect of a Mix of Dairy Lipids and Plant Oils in Infant Formula on Omega-3 Fatty Acid in Red Blood Cells
The objective of this study is to determine whether the use of a mix of dairy lipids and plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane phospholipids of red blood cells (RBC) in 4…
- Trial name
- REBECA (NCT01611649)
- Testing
- Formula containing dairy lipids and plant oils, Formula containing plant oils, Formula containing dairy lipids and plant oils, DHA+ARA
- Where
- Italy
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Lactalis
Infant Growth
Effect of a New Infant Formula With Specific Ingredients
The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in…
- Trial name
- EARLY-TOLERA (NCT04306263)
- Testing
- Enriched infant formula, Standard formula, Breastfeeding arm
- Where
- Spain
- Volunteers
- 231 people, healthy volunteers welcome
- Sponsor
- Laboratorios Ordesa
Infant, Small for Gestational Age
Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone
This non-interventional study for prospective follow up of a cohort of 220 subjects born small for gestational age (SGA) is planned for the purpose of finding out if normalisation of adult height is associated or not with…
- Trial name
- SGA (NCT01196156)
- Where
- 28 sites in Spain
- Volunteers
- 443 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infant Development
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.
- Trial name
- NCT03991949
- Testing
- Experimental Infant Formula
- Where
- 7 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Infant Development
Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants
The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth.
- Trial name
- NCT04749290
- Testing
- Study Formula
- Where
- 2 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Bunge Loders Croklaan
Dravet Syndrome
Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies
This is a multicenter, prospective, 2-year observational study in infants and children with developmental and epileptic encephalopathies (DEEs). The DEE currently being investigated is SCN1A-positive Dravet Syndrome.
- Trial name
- ENVISION (NCT04537832)
- Testing
- No Intervention
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 58 people
- Sponsor
- Encoded Therapeutics
Achondroplasia
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia
This trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs. placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg CNP/kg of Navepegritide…
- Trial name
- NCT06079398
- Testing
- Navepegritide
- Where
- 18 sites in United States, Australia and 13 more
- Volunteers
- 72 people
- Sponsor
- Ascendis Pharma A/S
Achondroplasia
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants < 3 years old with ACH.
- Trial name
- NCT07169279
- Testing
- Infigratinib is provided as a single dose of minitablets for oral administration, Infigratinib is provided as sprinkle capsules for daily oral administration
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 77 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Infant Nutrition, Cognitive Development
Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants: a Randomized, Controlled, Intervention Study
The purpose of this study is to demonstrate the efficacy of the nutrient blend in a starter infant formula (IF) and follow up infant formula (FUF) in improving the neurocognitive and behavioural outcomes among formula-fed infants…
- Trial name
- NCT05310396
- Testing
- Experimental formula, Control Formula
- Where
- Philippines
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Congenital Hypothyroidism
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH.
- Trial name
- NCT05228184
- Testing
- Tirosint®-SOL, Levothyroxine Sodium
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- IBSA Institut Biochimique SA
Pulmonary Hypertension, Familial Persistent, of the Newborn
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.
- Trial name
- NCT01720524
- Testing
- iv sildenafil
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 59 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Infant Development
Acceptability and Tolerance Study of an Amino Acid Formula with HMOs
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a hypoallergenic amino acid infant formula with HMOs for the dietary management of cows' milk allergy in infants less than 12 months of age.
- Trial name
- NCT04575298
- Testing
- Acceptability, tolerance study for an infant formula with human milk oligosaccharides
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cognitive Developmental Delay
Neurocognitive Follow-Up (FU) Study
This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA).
- Trial name
- NCT04962035
- Testing
- Neurocognitive Follow-up
- Where
- 3 sites in Poland, Slovakia
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals